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Intervention to Reduce Early (Peanut) Allergy in Children

Study Purpose

iREACH is a five-year NIH funded study aimed at assessing and improving pediatric clinician adherence to the 2017 NIAID Prevention of Peanut Allergy (PPA) Guidelines. iREACH has been developed as an electronic health record (EHR) integrated Clinical Decision Support (CDS) tool together with educational modules on the PPA guidelines to assist clinicians in implementing the 2017 NIAID PPA Guidelines. A practice-based, two-arm, cluster-randomized clinical trial will evaluate the effectiveness of iREACH in increasing pediatric clinician adherence to the PPA Guidelines and explore the end-goal of reducing peanut allergy incidence by age 2.5 years in the intervention vs.#46;control group. This study has the potential to: 1) provide evidence regarding the effectiveness of iREACH in promoting clinical processes and outcomes related to the PPA Guidelines, 2) provide important insight about practice-based implementation of PPA Guidelines by pediatric clinicians, allergists and caregivers, and 3) facilitate rapid, widespread implementation of PPA Guidelines and reduce peanut allergy incidence across the US.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Yes
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 4 Months and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

Practice sites.
  • - The practice utilizes a centrally-integrated EHR.
  • - The practice has signed a legally-binding engagement agreement with Lurie Children's Pediatric Practice Research Group.
  • - The practice employs at least one physician who has completed a residency in general pediatrics and is practicing as a general pediatrician.
Pediatric Clinicians:
  • - Clinician is a physician, physician assistant, resident, advanced practice nurse, family practitioner, or pediatric nurse practitioner working in a pediatric practice.
  • - Clinician is employed by a practice that is a member of one of the participating practices in the study.
  • - Clinician provides well child care to infants ages 4 or 6 months.
Infants • Infant has been seen by a pediatric clinician in the intervention or control arm for a 4- and/or 6-month WCC. Caregivers.
  • - Is the caregiver of an infant seen for a 4- and/or 6-month WCC by a pediatric clinician in a practice belonging to the study's intervention or control arms.
  • - Is 18+ years of age or has parent or guardian permission to participate.
  • - Is able to understand the study and provide informed consent for the 12- and 24-month (child's age) survey.

Exclusion Criteria:

Practice Sites.
  • - Sees <50 newborn patients/year.
  • - Has only temporary pediatricians on staff.
  • - The practice pediatric clinicians do not use an EHR system.
Pediatric clinicians.
  • - The clinician is a temporary employee.
  • - The clinician begins employment at participating practice less than three months prior to end of the 18-month study enrollment period.
Infants.
  • - The infant has a medical condition that chronically inhibits the ability to take food orally (i.e., dysphagia, muscular dystrophy, gastrostomy).
  • - The infant has past or current medical problems or findings from physical examination or laboratory testing not listed above for which the pediatric clinician indicates that implementation of PPA Guidelines may pose a medical risk other than allergic reactions or may interfere with the infant's appropriate implementation of the PPA Guidelines or study investigators conclude that implementation of the PPA Guidelines was not possible or may have impacted the quality or interpretation of the data obtained from the study.
Caregivers. • Caregiver's primary language is not English or Spanish.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04604431
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

N/A
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Ann & Robert H Lurie Children's Hospital of Chicago
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

Ruchi S Gupta
Principal Investigator Affiliation Ann & Robert H Lurie Children's Hospital of Chicago
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other, NIH
Overall Status Enrolling by invitation
Countries United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Food Allergy Peanut, Food Allergy in Infants
Additional Details

A minimum of 30 pediatric practice sites will be randomized to the iREACH intervention arm or to the control arm. Primary Objective To determine the effectiveness of iREACH in increasing adherence to the PPA Guidelines among pediatric clinicians. Secondary Objective To determine the effectiveness of iREACH in decreasing the incidence of peanut allergy by age 2.5. Exploratory Objectives. 1. To determine allergists' adherence to the PPA Guidelines. 2. To identify common barriers/facilitators for PPA Guideline adherence among pediatric clinicians and caregivers. 3. To determine caregiver adherence to the PPA Guidelines. All pediatric clinicians within each participating practice (n≈200 total) will be assigned to the arm to which their practice is randomized. The trial will be conducted over an 18-month period. During this time, approximately 500 high-risk infants and 10,000 low-risk infants are expected to be seen for 4- and 6-month well child care visit (WCC). The primary outcome, pediatric clinician adherence to the PPA Guidelines, will be assessed using EHR data for each infant following the 6-month WCC. Data for the secondary outcome will be obtained by a combination of EHR data extracted after the infant's 6-month WCC and data collected from caregivers. EHR data extraction will be performed to obtain data from the infant's 9-, 12-, 15-, 18-, 24-month WCC and any sick visits and allergist progress notes entered from 4-30 months of age. Caregivers' data will be collected via surveys of caregivers of children seen for 4- or 6-month WCC visits during the study period. Caregivers will be recruited and asked to provide informed consent at the time of the child's first birthday and questions will be asked to determine the incidence of peanut allergy. A follow-up survey will be sent to caregivers after the child's second birthday. Data for exploratory outcomes will be obtained through EHR data extraction and surveys of pediatric clinicians and the caregivers of infants seen for 4- or 6-month WCC. Pediatric clinicians in the intervention arm will be asked to provide informed consent and will complete three surveys over approximately 21 months. Pediatric clinicians in the control arm will be asked to provide informed consent following completion of data collection for the primary outcome and will complete one survey. Finally, caregivers, through the two surveys conducted at the time of their child's first and second birthdays, will provide information for exploratory outcomes.

Arms & Interventions

Arms

Experimental: Intervention (CDS Tool Integrated)

Pediatric clinicians in this arm will receive the iREACH CDS tool and education on the PPA Guidelines to support adherence to the Guidelines.

No Intervention: Control (No CDS Tool Integrated)

No study procedures will be implemented in the control practices, and their pediatric clinicians will not receive extra PPA Guidelines education, nor will any EHR modifications be made in their practices to support adherence to PPA Guidelines.

Interventions

Other: - iREACH CDS Tool

Pediatric clinicians in the intervention arm will 1) receive the iREACH education module, 2) have the iREACH CDS tool integrated into the EHR templates for use at the 4-, 6-, 9-, 12-month WCC, and 3) will be reminded by EHR-embedded prompts at the 9-month WCC to ask caregivers whether peanuts were introduced and tolerated.

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Arlington Heights, Illinois

Status

Address

Pediatric Associates of Arlington Heights, SC-PEDIATRUST

Arlington Heights, Illinois, 60005

Child and Adolescent Health Associates, Chicago, Illinois

Status

Address

Child and Adolescent Health Associates

Chicago, Illinois, 60610

NNHSC-Winfield Moody Health Center, Chicago, Illinois

Status

Address

NNHSC-Winfield Moody Health Center

Chicago, Illinois, 60610

Northwestern Children's Practice, Chicago, Illinois

Status

Address

Northwestern Children's Practice

Chicago, Illinois, 60611

Streeterville Pediatrics, Chicago, Illinois

Status

Address

Streeterville Pediatrics

Chicago, Illinois, 60611

Chicago, Illinois

Status

Address

Erie Family Health Centers - Erie Teen and Young Adult Health Center

Chicago, Illinois, 60622

Erie Family Health Centers - West Town, Chicago, Illinois

Status

Address

Erie Family Health Centers - West Town

Chicago, Illinois, 60622

Chicago, Illinois

Status

Address

Erie Family Health Centers - Helping Hands - Foster

Chicago, Illinois, 60625

NNHSC-Sunnyside Health Center, Chicago, Illinois

Status

Address

NNHSC-Sunnyside Health Center

Chicago, Illinois, 60640

Chicago, Illinois

Status

Address

Lurie Children's Primary Care (Town and Country)

Chicago, Illinois, 60642

NM SoNo Pediatrics, Chicago, Illinois

Status

Address

NM SoNo Pediatrics

Chicago, Illinois, 60642

NNHSC-Louise Landau Health Center, Chicago, Illinois

Status

Address

NNHSC-Louise Landau Health Center

Chicago, Illinois, 60651

NNHSC-North Kostner HC, Chicago, Illinois

Status

Address

NNHSC-North Kostner HC

Chicago, Illinois, 60651

NNHSC -Komed-Holman Health Center, Chicago, Illinois

Status

Address

NNHSC -Komed-Holman Health Center

Chicago, Illinois, 60653

Children's Healthcare Associates, Chicago, Illinois

Status

Address

Children's Healthcare Associates

Chicago, Illinois, 60657

Lakeview Pediatrics, Chicago, Illinois

Status

Address

Lakeview Pediatrics

Chicago, Illinois, 60657

Evanston, Illinois

Status

Address

Chicago Area Pediatrics (Drs. Traisman, Benuck, Merens & Kimball)

Evanston, Illinois, 60202

Erie Family Health Centers - Evanston, Evanston, Illinois

Status

Address

Erie Family Health Centers - Evanston

Evanston, Illinois, 60202

Pediatric Partners, SC-PEDIATRUST, Highland Park, Illinois

Status

Address

Pediatric Partners, SC-PEDIATRUST

Highland Park, Illinois, 60035

Hoffman Estates, Illinois

Status

Address

Drs. Bedingfield, Rosewell, Silver & Nourbash

Hoffman Estates, Illinois, 60169

Lake Shore Pediatrics, SC-PEDIATRUST, Libertyville, Illinois

Status

Address

Lake Shore Pediatrics, SC-PEDIATRUST

Libertyville, Illinois, 60048

OSF Medical Group (MG)-Morton Pediatrics, Morton, Illinois

Status

Address

OSF Medical Group (MG)-Morton Pediatrics

Morton, Illinois, 61550

UnityPoint Clinic Morton Pediatrics, Morton, Illinois

Status

Address

UnityPoint Clinic Morton Pediatrics

Morton, Illinois, 61550

Naperville Pediatric Associates, Naperville, Illinois

Status

Address

Naperville Pediatric Associates

Naperville, Illinois, 60540

AdPark Pediatrics, SC-PEDIATRUST, Northbrook, Illinois

Status

Address

AdPark Pediatrics, SC-PEDIATRUST

Northbrook, Illinois, 60602

Oak Park Pediatrics, Oak Park, Illinois

Status

Address

Oak Park Pediatrics

Oak Park, Illinois, 60302

Pekin, Illinois

Status

Address

UnityPoint Clinic Pediatrics Methodist Pekin

Pekin, Illinois, 61554

UICOMP-University Pediatrics, Peoria, Illinois

Status

Address

UICOMP-University Pediatrics

Peoria, Illinois, 61603

OSF-Center for Health (CFH)-Route 91, Peoria, Illinois

Status

Address

OSF-Center for Health (CFH)-Route 91

Peoria, Illinois, 61615

Peoria, Illinois

Status

Address

UnityPoint Clinic Pediatrics Methodist North

Peoria, Illinois, 61615

Woodfield Pediatrics, SC-PEDIATRUST, Schaumburg, Illinois

Status

Address

Woodfield Pediatrics, SC-PEDIATRUST

Schaumburg, Illinois, 60173

OSF Medical Group (MG) Washington, Washington, Illinois

Status

Address

OSF Medical Group (MG) Washington

Washington, Illinois, 61571

Erie Family Health Centers - Waukegan, Waukegan, Illinois

Status

Address

Erie Family Health Centers - Waukegan

Waukegan, Illinois, 60085

Wheaton Pediatrics, SC-PEDIATRUST, Wheaton, Illinois

Status

Address

Wheaton Pediatrics, SC-PEDIATRUST

Wheaton, Illinois, 60062

Pediatric Associates of the North Shore, Wilmette, Illinois

Status

Address

Pediatric Associates of the North Shore

Wilmette, Illinois, 60091

Elm Street Pediatrics, SC-PEDIATRUST, Winnetka, Illinois

Status

Address

Elm Street Pediatrics, SC-PEDIATRUST

Winnetka, Illinois, 60093

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